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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21723124
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
Spontaneous call from patient. Patient called and informed she has parts of the cleo infusion set stuck inside her from previous infusion sites, she stated this is the third time it occurred. She reached out to md office but was advised to reach out to (b)(6) specialty. There isn't any pain from the pieces stuck inside her, no bleeding or discharge from the scars. She was wondering of what can be done to prevent it from happening again. Advised i will have a nurse reach out to review insertion technique and/or review other infusion set options. Advised patient to monitor for signs of infection and inform md/(b)(6) immediately. No further information at this time. Reported to (b)(6) by pt/caregiver.
 
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Brand NameINF SET CLEO 31" 9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11723595
MDR Text Key247565937
Report NumberMW5100973
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21723124
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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